SOURCES SOUGHT
A -- NIAID HIV AIDS Scientific and Operations Support
- Notice Date
- 1/4/2007
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NIH-NIAID-DAIDS-07-46
- Response Due
- 1/17/2007
- Archive Date
- 2/1/2007
- Description
- This notice is for information and planning purposes only. This is not a request for proposals and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. Based on capability statements received from this sources sought notice, this acquisition may be solicited as a 100% small business set-aside or as full and open. All small business organizations (small business, small disadvantaged business, women-owned small business, HUB Zone small business, veteran-owned small business, small disadvantaged veteran-owned small business) are encouraged to respond to this notice. The NAICS code is 541710 with a size standard of 500 employees. The National Institute of Allergy and Infectious Diseases is seeking qualified small businesses that are capable of managing and have the capacity to provide the scientific, technical and operational support to NIAID HIV and AIDS research activities, particularly clinical research, conducted through grants and contracts. NIAID is currently supporting approximately 400 trials related to HIV and AIDS in various stages. These trials range from 10 to 6000 participants and are conducted in 46 countries. Approximately 22 of the 46 countries are resource poor. The Contractor may be asked to provide assistance, and assessment, or consultation related to any of the NIAID HIV AIDS funded clinical studies and be aware that NIAID sponsors multiple large, international trials at the same time. It is anticipated that one (1) level-of-effort type contract will be awarded for a period of two (2) years with options to extend the period of the contract up to five (5) additional years. It is estimated that seventy-seven (77) full time equivalents (FTE) will be required on a yearly basis. Options will also be included to increase the level of effort in any year in increments of ten (10) FTE. The maximum expansion would be eight (8) increments of ten (10) FTE for a total of 157 FTE. This contract is intended to augment the capacity of services provided by existing research support contracts to provide flexibility and scalability. Performance will involve daily interaction between the Contractor and NIAID federal staff for activities that require continuity, a high degree of collaborative problem solving, and time sensitive decision making. Contractor support shall be provided in the following major areas: 1) Clinical Research Support, 2) Program Research and Operations Support, 3) Communications Support, 4) Administrative Support, 5) Conflict of Interest Mitigation, Non-Disclosure and Confidentiality, and 6) Project Management. SERVICES REQUIRED: The NIAID is seeking small businesses that possess in-depth knowledge of the staffing and infrastructure requirements for large multi-site clinical trial efforts conducted in diverse international settings and who are capable of providing the additional services described below. CLINICAL RESEARCH SUPPORT: includes providing advice and assistance to NIAID staff in an advisory capacity in support of: 1) Development and review of clinical study concepts and protocols; 2) Clinical research site identification, assessment, preparation and training; 3) Clinical site preparation team visits and follow-up visits; 4) Clinical site visit scheduling and to track and manage of site visit reports and other materials necessary to document appropriate clinical, laboratory, pharmacy and data management facilities and services, staff and operating procedures; 5) Design and conduct of site and protocol-specific training; 6) Preparation and filing of Investigational New Drug (IND) Applications; 7) Ensure documentation of local Institutional Review Board (IRB) approval of protocols; 8) Approve essential documentation, as defined by the International Conference on Harmonization ICH-E6-GCP (http://www.fda.gov/cder/guidance/959fnl.pdf); 9) Ensuring that clinical sites have a supply of study products; maintain required documentation of study products 10) Ensuring site compliance with regulatory and protocol-specific requirements including data collection and data management, pharmacy facilities and services, laboratory compliance of site and specialized laboratories; 11) Ensuring safety oversight and monitoring; 12) Data and Safety Monitoring Board (DSMB) activities; 13) Biostatistical support; 14) Scientific and administrative laboratory projects resulting from NIAID participation in the Global Enterprise and related partnerships; 15) Designing, implementing and managing an efficient system for tracking clinical research documents and recording appropriate quality control of all documents needed for the life cycle of NIAID-sponsored clinical trials; 16) Identification and response to a broad range of regulations, policies and guidelines governing the conduct of research involving human subjects in domestic and international settings; and 17) Evaluation and development of clinical research training programs. PROGRAM RESEARCH AND OPERATIONS SUPPORT: includes providing advice and assistance to NIAID staff in an advisory capacity in support of: 1) Grant and contract portfolio tracking, analysis and monitoring; 2) Data management systems and data quality assurance for DAIDS-supported clinical and non-clinical research programs; 3) On-site scientific and technical activities conducted through cross-organization technical/scientific working groups, meetings, conferences, product reviews or project reviews; 4) Preparing responses to inquiries and requests for information concerning NIAID-funded research programs and policies from a broad range of audiences, including advocacy groups, health care professionals, health care research organizations, industry, investigators, Congress, other components of the Department of Health and Human Services, and other Federal agencies; 5)Development of public health policies for HIV/AIDS research in domestic and international settings; 6) Developing collaborations with a broad range of organizations and groups to ensure appropriate involvement and input into NIAID-sponsored HIV and AIDS research programs; 7)Research support for document development relevant to the issues that impact HIV and AIDS clinical programs, collaborations, and product development efforts. This may involve understanding clinical trial agreements, confidentiality or disclosure agreements, or strategies to facilitate private sector participation in NIAID programs; 8) Design and implementation of systematic evaluation of NIAID-sponsored research grants, cooperative agreements and contracts; and 9) Assessment, development and maintenance of data management systems and standardization of data reporting for DAIDS-supported clinical and non-clinical research programs including data quality assurance policies and procedures, including adherence to FDA and other regulatory requirements, standard operating procedures and beta testing of the DAIDS Enterprise System. COMMUNICATIONS SUPPORT includes providing advice and assistance to NIAID staff to educate, raise awareness and document the results of DAIDS-sponsored clinical and other research activities for relevant scientific and non-scientific constituencies. This includes: 1) Reviewing plans for community education, outreach and the recruitment and retention of study participants; 2) Identifying opportunities for understanding the purpose, processes and results of DAIDS-sponsored HIV-related research by various constituency groups; 3) Preparation and review of written materials and presentations concerning NIAID-sponsored HIV and AIDS research projects for scientific, press, and lay audiences. These materials must comply with Federal and NIH standards when developed for web distribution; 4) Maintaining and archiving information provided to audiences outside NIAID; 5) Obtaining user or reader feedback to improve communication effectiveness without compromising technical content or accuracy; and 6) Staffing exhibition booths at domestic and international conferences and meetings to distribute and discuss approved materials on NIAID research programs. ADMINISTRATIVE SUPPORT includes: 1) Data entry and tracking of NIAID employee time and attendance records using established systems; 2) Assisting NIAID in coordinating and scheduling of site visits and other activities requiring travel for staff of the NIAID, DAIDS-supported contractors and DAIDS-supported investigators, and 3) Coordination and support of Contractor staff travel. CONFLICT OF INTEREST MITIGATION, NON-DISCLOSURE AND CONFIDENTIALITY PLAN: The Contractor shall implement and monitor on an ongoing basis an organizational conflict of interest and non-disclosure/confidentiality plan, conduct an annual review and report and resolve breaches of the plan, and conduct training for all staff to ensure that these issues are consistently and effectively managed. PROJECT MANAGEMENT. The Contractor shall establish and manage an organizational structure to support contract performance. Specifically, the Contractor shall: 1) Ensure that Contractor staff are available to meet with the Project Officer or his/her designees at the offices of NIAID in Bethesda, Maryland, within two hours notice; for any staff on official travel, his/her "acting" shall be available; 2) Provide adequate office space to house all staff assigned to the contract, as well as associated office equipment and facilities; and 3) Develop and conduct a standard training program for all Contractor staff covering contract purpose and scope, organizational structure and supported research programs and research support contract,; Contractor organizational and management structure, Standard Operating Procedures for internal assignment, monitoring of tasks, and mitigation of conflicts of interest, disclosure and confidentiality concerns. CAPABILITY STATEMENT REQUIREMENTS: Interested parties must be able to demonstrate in the capability statement the experience and ability to perform work described in this notice. This documentation may include examples of contracts, references, and any other relevant information. In order to be deemed capable, small business organizations should submit capability statements that include: 1)Demonstrated experience with contracts of similar size and scope to this proposed effort. Contract projects listed may include those entered into by the US Federal Government, agencies of state or local governments, for-profit and non-profit entities; 2) Proposed key personnel that demonstrate that your organization has the necessary expertise to perform the requirements of the project; 3) Sufficient corporate qualifications needed to perform the requirements of the project; 4) A statement identifying the offeror as a small business firm; 5) A satisfactory strategy to be used to mitigate individual and institutional conflicts of interest, disclosure and confidentiality concerns; and 6) Demonstrated capability to rapidly identify and recruit personnel, administer and coordinate interrelated tasks and familiarity with national and international regulations and requirements related to clinical trials. Any organization responding to this SOURCES SOUGHT notice should ensure that it?s response is complete and sufficiently detailed to allow the Government to determine the organization?s qualifications to perform this work. Written capability statements must be received no later than January 17, 2007 by 4:00 p.m. (EST time). These submissions must be submitted by E-mail (ONLY) to Ms. Anita Hughes, Contract Specialist, at anhughes@niaid.nih.gov. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the Subject line Reference: NIH-NIAID-DAIDS-07-46. Facsimile and Hand Carried submissions will not be accepted. All inquiries concerning this announcement shall be directed to Ms. Anita Hughes or Ms. Eileen Webster-Cissel (telephone number 301-496-0612).
- Place of Performance
- Address: N/A
- Zip Code: 20892
- Country: UNITED STATES
- Zip Code: 20892
- Record
- SN01205049-W 20070106/070104220250 (fbodaily.com)
- Source
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